CQV 

Commissioning, Qualification, and Validation

PSC Biotech® provides end-to-end solutions for commissioning, qualification, and validation

Our team of professionals supports life science companies in all aspects of the CQV lifecycle. We facilitate a timely and cost-effective solution tailored to your company’s budget and requirements.

Our Expertise

  • Facilities Equipment
  • Utilities Equipment
  • Processes
  • Cleaning Validation
  • Test Method Validation
  • Greenfield CQV Projects​
  • New Production Suite Commissioning​
  • Decommissioning

End-to-End Solutions

  • Project Planning
  • Validation Master Plans (VMP)
  • User Requirements Specifications (URS)
  • Risk Assessments
  • Protocols
  • FAT
  • SAT
  • Summary Reports
  • Traceability Matrixes
  • Calibration Matrix
  • SOPs
  • Integrated Commissioning and Qualification (ICQ) ​​
  • Validation Protocol Format​
  • Design Qualification (DQ)​
  • Installation Qualification (IQ)​
  • Operational Qualification (OQ)​
  • Performance Qualification (PQ) ​
  • Good Automated Manufacturing Practice (GAMP)​
  • Current Good Manufacturing Practice (cGMP) Review​
  • Continued Process Verification (CPV)​
  • Pre-Operational Verifications ​
  • Commissioning and Startup
  • Technical Audits and Due Diligence

PSC Biotech® is one of the largest providers of Commissioning, Qualification, and Validation services in the life science industry. The PSC Biotech® CQV team consists of seasoned experts in validating facilities, utilities, equipment, computer systems, processes, cleaning, test methods, and more. PSC Biotech® has the experts you need for services ranging from creating a validation protocol format, a validation master plan (VMP), training, technical audits, and due diligence to software validation, paperless validation, and more.

PSC Biotech® has commissioning engineers to assist you in projects large or small. PSC Biotech® engineers readily facilitate greenfield facility startup services and facility remediation services with integrated commissioning and qualification (ICQ), Good automated manufacturing practice (GAMP), Continued process verification (CPV), Pre-Operational Verifications, Validation and Verification (V&V), Processed Analytical Technology (PAT) capabilities. We provide end-to-end solutions with expertise in project planning, CQV master planning, requirement specifications, risk assessments, commissioning, decommissioning, FATs, SATs, installation qualifications, operational qualifications, performance qualifications, summary reports, traceability matrixes, calibration, temperature and humidity mapping services, and more.

Our consultants have access to our global Subject Matter Experts and training materials 24/7 and guarantee quality when delivering your projects. Our team of professionals can support your company in the entire CQV lifecycle. We facilitate a timely and cost-effective solution curated for your company. By outsourcing your CQV needs, you can focus on other aspects of your company while also accelerating your business. While working with PSC Biotech®, your organization will continuously gain insightful knowledge to grow your company.

PSC Biotech® Industry Expertise

Cosmetics, Cannabis

Pharmaceuticals, Personalized Medicine

Medical Devices, Biotechnology

Tissue Products, Cell and Gene Therapy

Food & Beverages, Homeopathic, Nutraceuticals

PSC Biotech® Commissioning, Validation, and Qualification consultants work to your project needs. To start the process of gaining a PSC Biotech® CQV consultant to design, validate, implement, optimize, review, investigate, audit, or otherwise assist in commissioning, qualification, and validation, contact us today! See our project success pages for examples of our CQV projects with life science companies.

Examples of routine projects for PSC Biotech® CQV engineers include equipment validation and qualification of chambers, autoclaves, tunnels, lyophilizers, packaging, shipping, related process equipment, and associated document generation and revision.

 

Download Our CQV White-Paper

What Our Clients are Saying

“During the past year, our company has been working with PSC on various activities within the development and implementation of a new medical device product. PSC offers high quality services, and we can say that we have always been satisfied by their work.”

“The skillsets that PSC provides in regulatory support helped us overcome a large obstacle in particular. The regulatory support that we had from PSC was very independent and if we had an issue, PSC consultants were willing to work cross-functionally to meet our needs. No micromanaging required. Great communication. Minimal supervision. I don’t think we would have been as successful without them. The expertise and the connections we’ve created with PSC are beyond our expectations. I’ve never had that relationship with a company like I’ve had with PSC. Just phenomenal! It made my life easier.”

“This is to certify that PSC Biotech® (PSC) has done a good job for our company in the range of auditing and consultancy. Their work was remarkably distinguished as auditors. As consultants, their work was successfully handled and enabled based on the level of expertise of their team in the U.S. and abroad.”

Related Projects

20 Years & Counting of CQV Services

Commissioning, Qualification, and Validation (CQV) services for one of the clients plants since the mid 1990’s to the present.

Cleaning Validation & Decommissioning Project

PSC hired a validation specialist who stayed within budget and the time frame set originally by PSC and the client.

Sterile Fill/Finish Laboratory Facilities CQV Project

The operations performed included: Filling, Parts Preparation, Formulation, Filling, Process Support Systems and Cleaning.

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